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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ SYRINGE; PISTON SYRINGE
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BECTON DICKINSON, S.A. BD PLASTIPAK¿ SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 305959
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 03/22/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported 2 bd plastipak¿ syringe had leakage issues.The following information was provided by the initial reporter: ".Leaked out at the connection point between the green needle and the 10ml syringe.".
 
Manufacturer Narrative
H.6.Investigation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for suspected lot 2110129, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Ten retained samples of lot 2004260 were used for additional evaluation.The product was visually inspected, no defects or damage was noted and testing verified the product met required specification.Based on the available information we are not able to determine a root cause at this time.
 
Event Description
It was reported 2 bd plastipak¿ syringe had leakage issues.The following information was provided by the initial reporter: ".Leaked out at the connection point between the green needle and the 10ml syringe.".
 
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Brand Name
BD PLASTIPAK¿ SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14116047
MDR Text Key289446017
Report Number3003152976-2022-00137
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305959
Device Lot Number2110129
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/22/2022
Initial Date FDA Received04/14/2022
Supplement Dates Manufacturer Received05/05/2022
Supplement Dates FDA Received05/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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